Ever since the appearance of the new revision of the ISO 9001 standard was published, I see incessant discussions of frightened Quality Assurance people on the differences between the revisions of 2015 and that of 2008, as well as a multitude of classes and trainings promising to help with the transition from the previous to the new.
However, as I am coming from a different approach, in my opinion, and of those who share my or similar approach, there is little real difference between the new, 2015 revision and the previous one. (more…)
In Quality Assurance, what is the beginning of any process? Its definition, born from need.
The ISO 9001 standard instructs us to identify the processes in our organization and record them. That is, to decide how we perform them and to write that down, so everyone may verify in the future, if they forget. We call that record “procedure”.
Everyone knows a company must have procedures. Quality or no quality, but everything must be written down in procedures and they must be followed.
As a sort of God’s will.
And if it is Quality procedures we are talking about – so much the worse. A lot more annoying, too. Here come those bureaucrats from QA with their accursed paperwork…
So I thought we could take a look at what procedures actually are, and why they are needed.
From my long years of experience, I found that most people think Quality Assurance deals with products, specifications and their parameters, or requirements. Various management members often hold the conviction that it is Quality Assurance department which holds the responsibility for the quality of their products, whereas they do not fulfill these specifications.
Is that really so?